OncoMatch/Clinical Trials/NCT06385418
Fluorouracil Treatment Via Colon for Colorectal Cancer
Is NCT06385418 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Colonic local administration of fluorouracil with enhanced adhesion for colorectal cancer.
Treatment: Colonic local administration of fluorouracil with enhanced adhesion — Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L
Kidney function
Creatinine <120 μmol/L, or MDRD eGFR >60 mL/min
Liver function
Total bilirubin ≤1.5x ULN (≤3x ULN with biliary drainage); ALT and AST ≤5x ULN; for patients with liver metastases, serum total bilirubin ≤3x ULN
Cardiac function
LVEF ≥50% by Doppler echocardiography
Adequate organ function meeting the following criteria: (1) Absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L; (2) Total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); ALT and AST ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) Creatinine <120 μmol/L, or MDRD estimated glomerular filtration rate >60 mL/min; (4) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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